JP2002541900A - Restoration device for use in surgical procedures - Google Patents

Abstract

SUMMARY [57] The present invention is an apparatus (900) for repairing a blood vessel during a surgical procedure. The device (900) includes a housing (910), a penetrating device (7) for use in forming a treatment-specific hole in the blood vessel, and a visualization device for viewing the interior of the blood vessel during a surgical procedure. At least one of (6) is included. The housing (910) includes a plurality of layers surrounding the central path (911). Housing (910) further includes at least one lumen formed in one of the plurality of layers. Apparatus (900) further includes a positioning assembly (920).

Description

DETAILED DESCRIPTION OF THE INVENTION

(Explanation of Related Application) [0001] This application is related to US Provisional Application No. 60/051, filed on June 30, 1997.
No. 08 / 896,415, filed Jul. 18, 1997, claiming priority to US Patent No. 4/1999, which is a continuation of No./958,524
Claims priority to US patent application Ser. No. 09 / 293,175 filed on Mar. 16, 2009.

BACKGROUND OF THE INVENTION TECHNICAL FIELD The present invention relates to treatment-specific holes (t) in both vascular and artificial grafts during surgical procedures.
A method and apparatus for repairing abdominal aortic aneurysms using a novel penetrating device to form treatment specific holes.

[0003] 2. 2. Description of the Related Art An aneurysm is a swelling of the artery wall that results from weakening of the artery due to disease or other conditions. If left untreated, the aneurysm often ruptures, resulting in blood loss and death.

[0004] Aortic aneurysms are the most common form of aneurysm and are life-threatening. The aorta is the main artery that supplies blood to the circulatory system. The aorta originates from the left ventricle of the heart,
Flexes behind the heart, going upwards and going down through the chest and abdomen. Among other arterial blood vessels that branch the aorta along the path, the abdominal aorta supplies the kidney with two side vessels, the renal artery. Below the level of renal vessels, the abdominal aorta continues around the level of the fourth lumbar vertebra (or umbilical), where it splits into the iliac arteries. This iliac artery, in turn, supplies blood to the lower tip and surrounding area.

[0005] Aortic aneurysms commonly occur in the abdominal aorta between the renal arteries and the iliac arteries. This part of the abdominal aorta is particularly vulnerable, resulting in an aortic aneurysm. Such aneurysms are often located near the iliac arteries. Aortic aneurysms in which the diameter of this part of the aorta is greater than about 5 cm are severe. If left untreated, the aneurysm ruptures, resulting in rapid and usually fatal bleeding. Generally, surgical procedures for aneurysms smaller than 5 cm are not performed because there is no statistical advantage of performing such procedures.

[0006] Aneurysms in the abdominal aorta are particularly associated with high mortality, and therefore current medical standards require emergency surgical repair. However, laparotomy results in substantial stress on the body. Aortic aneurysm mortality is very high, but there is also considerable mortality and morbidity associated with open procedures to repair the aneurysm. This procedure involves penetrating the abdominal wall to the site of the aneurysm, strengthening or replacing the diseased part of the aortic aneurysm. A displacement device, typically a synthetic tube graft, is used for this purpose. The graft helps to remove the aneurysm from the circulatory system, thus reducing pressure and stress on the weakened portion of the aorta in the aneurysm.

[0007] Repair of aortic aneurysms by surgical means is a major surgical procedure. Substantial morbidity accompanies the treatment, resulting in a delayed recovery period. In addition, treatment involves substantial mortality risk. While there are indications for surgical procedures and the risks associated with surgery, some patients may not tolerate the stress of intraperitoneal surgery. Therefore, it is desirable to reduce mortality and morbidity associated with intraperitoneal surgical procedures.

In recent years, methods have been developed that attempt to treat aortic aneurysms without the risks associated with intra-abdominal surgical procedures. Among them, Kornberg for aortic grafts, devices and methods for performing endoluminal abdominal aortic aneurysm repair
U.S. Pat. No. 4,562,596 to Lazarus, U.S. Pat. No. 4,787,899 to endoluminal graft devices, systems and methods, and Taheri to intravascular staplers and methods of surgery. )
The invention in U.S. Patent No. 5,042,707 is disclosed and claimed.

Kornberg discloses an aortic graft that includes a flexible tubing having a plurality of struts that causes the safety and elasticity of the graft. The strut has angled hooks with a bar at its upper end to ensure attachment inside the aorta over the aneurysm. The Kornberg graft is inserted using the tubular device also disclosed in his patent. However, only Kornberg fixed the proximal end of the graft,
Kornberg claims that no downward mechanical attachment is required to ensure that the downward blood flow properly holds the distal graft. However, the abdominal aortic blood pressure is typically on the order of 130 mm Mercury (Hg). Despite the direction of blood flow through the proximal to distal graft, unless the distal end is also mechanically attached to the aorta to prevent substantial leakage of blood between the graft and the aorta ,
It causes substantial back pressure within the aneurysm. Without the distal attachment, the Kornberg device does not efficiently relieve the forces and stresses associated with blood pressure.

[0010] Lazarus discloses an implantation system that uses multiple staplers attached to the proximal end of a graft. The Lazarus stapler is forced through the aortic wall by a balloon catheter. Like Kornberg, Lazarus discloses a stapler that is attached only to the proximal end of the graft. No. 4,787,899 to Lazarus does not disclose or suggest the means, needless to say, of the desirability of mechanically attaching the graft to the distal aorta below the level of the aneurysm.

[0011] Taheli discloses an articulated stapler for implanting a graft in a blood vessel. The stapler is in the form of an elongated catheter with a number of sections attached to the distal end of the catheter. Each part has an inclined surface and is connected to each other by a hinge. The stylet is displaced through the catheter to the most distal portion. The distal-most portion, in cooperation with the other portions, moves to a firing position that is substantially perpendicular to the catheter body by tension on the stylet. The staple is implanted with two other stylets that act as fingers to bend the staple into its attachment location.

[0012] However, the helicopter appears to be a single-firing design in which only one staple can be implanted at a time. After each stapler has been implanted, it is clear that the design of the helicopter requires that the catheter be removed before loading another stapler. Also, the helicopter design does not disclose or suggest an appropriate density of staplers to secure the graft against the pulsatile blood flow of the aorta. The pressure range in the aorta is between 120 mmHg pressure and 200 mmHg pressure. Without proper attachment, the graft may leak around the ends, continue to produce life-threatening pressure on the aneurysm, and may migrate.

[0013] Thus, in recent years, certain methods have been developed that can reduce the risk of stress, morbidity, and mortality associated with surgical procedures to repair aortic aneurysms. Nothing effectively treats the aneurysm and excludes the affected area of the aorta from the pressure and stress associated with circulation. Of the devices disclosed in the references, there is no reliable and quick means to strengthen the aneurysm artery. Also, all of the above references require a sufficiently large portion of the healthy aorta around the aneurysm to ensure graft attachment. The neck of the aorta at the cranial end (ie, above the aneurysm and cranially) is usually sufficient to maintain the graft attachment means. However, when the aneurysm is located near the iliac arteries, the neck below the aneurysm is unclear or completely absent. Such an unclear neck results in an insufficient amount of healthy aortic tissue to effectively attach the graft. In addition, much of the abdominal aortic wall is calcified, making it very difficult to attach the graft to the wall.

[0014] Currently available graft products and their fixation within the abdominal aorta have many disadvantages. Sizing of "tubular" or "branched" grafts is evaluated on radiographs prior to surgery, but it is the surgeon's responsibility to make large choices in graft length and diameter to ensure adequate surgical results . Another disadvantage is the placement of grafts of "annular" shape with ancillary fixation devices in blood vessels that are essentially "oval" and structurally impaired insubstantial vascular walls (disease ) The use of attachment means to fix only the intima and media levels. Studies have revealed yet another problem indicating that the size of the postoperative aortic neck increases in about 12 months, regardless of whether the aneurysm undergoes a change in dimensions. This phenomenon results in leakage around the graft and dislocation of the graft.

[0015] Many scanning methods are currently available that facilitate preoperative evaluation of abdominal aortic aneurysms. These scanning methods include computed tomography; nuclear magnetic resonance angiography; computer angiography; tomography including Doppler and color flow; abdominal aortic angiography; contrast arteriography; , MRI); and echocardiography. Although the images obtained by these scanning methods are useful, there is room for multiple interpretations because the portion of the aorta to be repaired cannot be seen directly. Furthermore, the performance of these methods of treatment is harmful to the patient and is otherwise impractical.

OBJECTS OF THE INVENTION It is therefore an object of the present invention to provide a new and improved means for repairing abdominal aortic aneurysms.

Another object of the present invention is to provide a device for facilitating repair of abdominal aortic aneurysms.

Another object of the present invention is to provide a graft for repair of abdominal aortic aneurysm.

It is an object of the present invention to provide a device for aneurysm repair that facilitates direct viewing of the site of the aneurysm to be repaired.

It is another object of the present invention to reduce the amount of damage to the aorta and associated vasculature during repair of an aneurysm.

Another object of the present invention is to facilitate direct viewing of the vessel wall surface to assist a medical practitioner (ie, surgeon or interventional radiologist) in vascular repair.

An object of the present invention is to eliminate an aneurysm from the circulatory system.

It is an object of the present invention to create a device for the repair of aneurysms that can steer vessels that extend into and out of the aorta without negative consequences.

Another object of the present invention is to place a graft in the abdominal aorta between the proximal and distal ends of the aorta.

It is an object of the present invention to firmly secure the graft to the adventitia of the vessel wall and to prevent translocation of the graft.

Another object of the present invention is to create a device for clearly visualizing the surgical site when repairing an aneurysm.

[0027] Another object of the present invention is to make a uniform generic graft sized for use in a range of patients.

Another object of the present invention is to create a graft whose performance is not adversely affected by post-operative changes in the dimensions of the aortic neck.

Another object of the present invention is to provide, in addition to classic femoral / common iliac transduction, the repair of previously unconsidered abdominal aortic aneurysms introduced via the axillary and / or brachial arteries. Is to make a device for this.

It is another object of the present invention to provide a sealing detail within an introducer sheath device that significantly reduces blood loss during a repair procedure.

Another object of the present invention is to provide a fastening device assembly that replaces suturing.

It is another object of the present invention to provide a device that allows for the on-board storage of a treatment-specific amount of a locking device, without having to remove the reloading device during a repair procedure.

Another object of the present invention is to create a graft and device for aneurysm repair that reduces the invasiveness of current surgical procedures.

Another object of the present invention is to create a graft that is not dimension dependent (ie, diameter / length) but is adaptable to the patient's environment.

SUMMARY OF THE INVENTION The present invention is directed to a repair device for repairing a blood vessel during a surgical procedure. The device includes a housing and at least one of a penetrating device for use in forming a treatment-specific hole in the blood vessel and a visualization device for visualizing the interior of the blood vessel during a surgical procedure. The housing includes a plurality of layers surrounding a central path, the central path being adapted to receive at least one of the penetrating device and the visualization device.

[0036] The housing further includes at least one lumen formed in one of the plurality of layers. Also, the at least one lumen may include a plurality of lumens, the plurality of lumens being disposed adjacent the central channel. The plurality of lumens and the central passage can be coaxial.

The housing has a proximal end and a distal end. The repair device further includes a distal end assembly disposed adjacent the distal end of the housing. The distal end assembly allows access to one vessel of the penetrating device and the visualization device.

[0038] The repair device further includes at least one engagement line for controlling the articulation of the distal end assembly. At least one engagement line extends from a distal end of the housing to a proximal end of the housing. At least one engagement line is adapted to be connected to the repair controller, and manipulation of the at least one engagement line adjusts the orientation of the distal end assembly within the vessel. The housing may further include at least one lumen formed in one of the plurality of layers, wherein at least one engagement line extends through the at least one lumen.

A repair device according to the present invention may further include a positioning assembly for positioning the repair device in a blood vessel. The positioning assembly can be located adjacent one end of the housing. The repair device may further include a control assembly for controlling the orientation of the positioning assembly. The control assembly extends within the housing. The positioning assembly includes an inflatable assembly. The inflation assembly includes at least one lumen extending through one of the plurality of layers, and at least one inflation port connected to the at least one lumen, wherein the at least one inflation port is at a proximal end of the housing. They are located adjacent to each other.

[0040] The housing of the repair device includes a plurality of layers having a central path and at least a first layer surrounding the wire blade layer. The plurality of layers may further include an outer layer surrounding the wire blade layer. The plurality of layers may further include a protruding layer positioned between the first layer and the wire blade layer. At least one lumen is formed in the outer layer.

[0041] The repair device can further include a guide line extending through one of the at least one lumen. The repair device may further include at least one engagement line extending through the lumen.

The penetrating device according to the present invention may include a laser propelled low OH polyimide coated optical fiber. Alternatively, the penetrating device can include a piezoelectric catheter. Alternatively, the penetrating device can include a high or radio frequency powered electrocautery probe.

The present invention also relates to a fastening device for use during a surgical procedure for securing a surgical component to a vessel wall. The locking device includes a flexible locking assembly for securing a surgical component to a vessel wall under compressive force. The locking assembly couples the surgical component and a first portion located on one side of the vessel wall, a second portion located on another side of the surgical component of the vessel wall, and the first and second portions. An intermediate portion extending through the vessel wall and the surgical component. The first portion, the second portion, and the intermediate portion act to apply a compressive force to the surgical component and the vessel wall to secure the surgical component to the vessel wall. The locking assembly includes at least one auxiliary locking element for fixing a surgical component to a vessel wall, wherein the at least one auxiliary locking element is disposed on at least one of the first and second parts. You.

The locking assembly can include at least one spring assembly, and the auxiliary locking element can include at least one auxiliary spring assembly. According to the present invention, the first portion, the second portion, and the at least one auxiliary spring assembly can extend substantially parallel to the vessel wall.

The locking assembly may be a plurality of wound coil springs.

The auxiliary locking assembly may include a first auxiliary spring assembly connected to a first portion of the locking assembly and a second auxiliary spring assembly connected to a second portion of the locking assembly. it can. The locking device further includes an assembly for connecting at least a portion of the at least one auxiliary spring assembly to the spring assembly.

The locking device has a first direction for inserting the locking device through the vessel wall and the surgical component, and a second direction when the locking device is in the locked position. The spring assembly and at least one auxiliary spring assembly may be configured such that the locking device is a first
When oriented, they can be aligned along the longitudinal axis. The spring assembly and at least one auxiliary spring assembly move relative to each other from the longitudinal axis when the locking device is in the second direction.

[0048] The locking device is taut when in the first direction and relaxed when in the second direction, the locking device further includes a control for controlling compression of the locking device in the first direction. Includes control assembly. The spring assembly and the at least one auxiliary spring assembly may be a coil spring having a plurality of individual coils therein. The control assembly may be located between a plurality of individual coils.

[0049] The control assembly may include a suture line positioned between the plurality of individual coils. The suturing line can be formed of a dissolvable material such that the suturing material dissolves after the fastening device is in the second orientation.

The control assembly may include a soluble material formed on the lock assembly and the auxiliary lock assembly.

The present invention also relates to a fastening device for use during a surgical procedure for securing a surgical component to a vessel wall. The locking device includes a locking assembly for securing a surgical component to a vessel wall under compressive force. The locking assembly includes a surgical component and a first portion located on one side of the vessel wall, and a second portion located on another side of the surgical component of the vessel wall.
A portion has an intermediate portion coupled to the first and second portions, the intermediate portion extending through the vessel wall and the surgical component. The first portion, the second portion, and the intermediate portion act to apply a compressive force to the surgical component and the vessel wall to secure the surgical component to the vessel wall. The locking assembly has a first direction for inserting the locking assembly through the vessel wall and the surgical component, and a second direction when the locking assembly exerts a compressive force on the surgical component and the blood vessel. . The locking assembly may be taut when in the first direction. The locking device further includes a control assembly for controlling compression of the locking assembly in the first direction.

The present invention also relates to a visualization device for observing the inside of a blood vessel before, during and after a surgical procedure. The visualization device includes a housing and image generation means for generating an image of the inside of a blood vessel from inside the blood vessel. The image generating means is arranged in the housing. The image generating means includes an irradiating means for irradiating a site in the blood vessel for the user to observe. The image generating means also includes a deflecting means for temporarily deflecting the body from the observation site. The image generating means also includes an optical observation means for observing a site in a blood vessel.

The irradiating means may include at least one optical fiber for irradiating a site in a blood vessel.

The visualization means includes a means for supplying a liquid to the site and directing a blood flow from the observation site, and a reflux means for discharging the liquid from the site and returning the blood.

The optical observation means includes an optical fiber. Alternatively, the optical viewing means can include means for scanning a vascular site to generate a non-optical image of the site. The scanning means can generate an ultrasound image. The scanning means can include a scanning catheter.

The present invention also relates to a penetrating device for use in creating a plurality of treatment-specific holes in the often calcifying vessel wall to assist in graft attachment. The piercing device includes a housing and piercing means for use in creating a plurality of treatment-specific holes in the often calcified vessel wall. The piercing means is located in the housing. The penetrating means can include a laser. The laser may be an acousto-optic laser or a holmium YAG laser. Alternatively, the penetrating means can include a piezoelectric penetrating catheter. The penetrating means may include a high or radio frequency driven electrocautery probe. The penetrating device may also include an insertion means for inserting the locking device through the opening in the blood vessel and securing surgical components (eg, grafts and artificial aids) to the blood vessel wall. The penetrating device can also include a second penetrating means for forming at least one opening adjacent to the opening of the vessel wall that often becomes calcified. The second penetrating means may include a laser fiber, a piezoelectric device or an electrocautery probe. The second penetrating means stabilizes the penetrating device when the inserting means inserts the locking device of the first opening. The penetrating device can further include visual tracking means for ascertaining the position of the penetrating device within the blood vessel.

The present invention also relates to a repair device for repairing a blood vessel during a surgical procedure. The device includes a housing, at least one penetrating device for use in forming a vessel opening having a calcified portion, and a visualization device for viewing the interior of the vessel during a surgical procedure. The penetrating device includes a penetrating housing and penetrating means for forming a treatment-specific hole in the often calcified vessel wall. The visualization device includes a visualization housing,
Image generating means for generating an image of the inside of the blood vessel from inside the blood vessel.

The present invention also relates to a fastening device for use in a surgical procedure for securing a surgical component to a blood vessel. The locking device includes locking means for securing the surgical component to the blood vessel under compressive force. The securing means is either a wire structure or a coil spring structure.

The present invention also relates to an introducer sheath device for use during a surgical procedure for introducing a surgical component into a blood vessel. The introducer sheath device includes a housing having a passage that allows passage of a surgical component therein. The introducer sheath device also includes a proximal end sealing means to prevent blood loss from the blood vessel during insertion of the surgical component during a surgical procedure and subsequent removal. The sealing means includes a sealing cavity. The sealing cavity is filled with a sealing material that is inserted during the surgical procedure and forms a seal around the surgical component when removed from the introducer sheath device. The introducer sheath device further includes positioning means for maintaining the position of the introducer device within the blood vessel. Preferably, the positioning means comprises an inflatable cuff located at the distal end of the introducer sheath device.

BEST MODE FOR CARRYING OUT THE INVENTION The following description of a preferred embodiment of the present invention relates to the repair of abdominal aortic aneurysms.
Described for illustrative purposes. The inventors of the present subject matter believe that the embodiments described herein can be used in other vascular repairs and other procedures. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

Repair Graft Reference is made to details of a preferred embodiment of a graft according to the invention for repairing abdominal aortic aneurysms, an example of which is shown in FIGS.

FIGS. 1 and 3 show a preferred embodiment of the repair graft assembly of the present invention directed to a proximal graft assembly 10 and a distal graft assembly 20 for repair of a blood vessel 1. The proximal graft assembly 10 and the distal graft assembly 20 are secured to the wall 2 of the blood vessel 1 to eliminate the aneurysm from the patient's circulatory system.
In a preferred embodiment of the present invention, proximal graft assembly 10 is a branch graft.

The distal graft assembly 20 preferably includes an attachment cuff 21.
Attachment cuff 21 is sized to secure distal graft assembly 20 to wall 2 of blood vessel 1 at the distal end of blood vessel 1. Distal graft assembly 20 also includes at least one graft attachment leg, tube or branch 22. The attachment cuff 21 is fixed to the wall 2 of the blood vessel 1 outside the adventitia using a suitable fastening device, which will be described in detail below.

The distal graft assembly 20 is connected to the distal end of the blood vessel 1 as shown in FIG. 1 using a guide wire (not shown) extending between and through both common iliacs. Are located in The attachment cuff 21 is further secured to the distal end of the blood vessel 1 outside the adventitia using a repair device described below. After the attachment cuff 21 is firmly fixed to the wall 2, the attachment cuff 22 is fitted into the position shown in FIG. Next, the proximal graft assembly 10 is secured to the attachment leg 22 using a suitable connector, such as a self-expanding stent 30, as shown in FIG.

The bifurcated proximal graft assembly 10 includes a pair of tubular legs 11. Tubular leg 11 is sized to be received in / without graft attachment tube 22. Bifurcated proximal graft assembly 10 may also include an attachment cuff 12 for attaching to wall 2 of blood vessel 1. The attachment cuff 12 has the same structure as the attachment cuff 21 of the attachment device 20. Tubular leg 11
Is fitted after the process of fixing the attachment cuff 12 to the wall 2. The attachment leg 22 may be arranged in the tubular leg 11, as shown in FIG.
Alternatively, the tubular leg 11 may be arranged in the attachment leg 22, as shown in FIG.

It is also envisioned that the distal graft assembly 20 can be used with a standard vascular graft 3, as shown in FIGS. In this variant, the vascular graft 3 is attached to the wall 2 of the blood vessel 1 while in the reverse position, as shown in FIG. 2, using a locking device described below and, if necessary, a self-expanding stent 30. Fixed.
The vascular graft 3 is then fitted and secured to the distal graft assembly 20, as described above. The advantage of fitting the graft 3 is that the locking device for fixing the graft 3 to the blood vessel 1 does not come into direct contact with the blood in the blood vessel 1. This reduces the potential for thrombus formation and subsequent emboli formation at the point of attachment.

The proximal graft assembly 10 and the distal graft assembly 20 allow for the creation of a cross-sectional area ratio between the common iliac and the distal aorta, which is present only in children. This ratio appears to be between 1.1 and 1.0. This ratio minimizes reflected waves that help generate plaque deposits at the distal branch.

FIGS. 5 and 6 show another embodiment of a repair graft for repairing an abdominal aortic aneurysm 1 according to the invention. The proximal graft assembly 100 is secured to the wall 2 of the abdominal artery and removes the aneurysm 1 from the patient's circulatory system. The proximal graft assembly 100 includes
Used in connection with the distal graft assembly 20 described above. In this embodiment, distal graft assembly 20 includes a single attachment leg or tube 22. The proximal graft assembly 100 includes a vascular graft assembly 110 for forming a passage in the blood vessel 1.

The radially extending attachment cuff 121 provides a large surface area for securing the proximal graft assembly 100 to the wall 2. Also, the radially extending portion 121 is flexible, which allows for positioning adjustment of a portion of the proximal graft assembly 100 even if the size of the passage in the abdominal aorta changes after the surgical procedure. Becomes FIG. 11 shows the flexibility of the attachment cuff 21 which is similar to the attachment cuff 121. As in FIGS. 1 and 3, the proximal graft assembly 100 is secured to the vessel wall 2 in a fitting manner, as shown in FIG.
After the attachment cuff 121 has been secured to the vessel wall 2, the proximal graft assembly 100 is inserted into the position shown in FIG. Next, the tubular leg assembly 110 is secured to the distal graft assembly 20, as shown in FIG. In a preferred embodiment, a self-expanding stent 30 is used to secure it to the attachment leg 22 of the distal graft assembly 20. Self-expanding stent 30 applies radial pressure to the inner surface of vascular graft assembly 110 to secure vascular graft assembly 110 to distal graft assembly 20.

Self-expanding stent 30 is a preferred method of securing proximal tube assembly 10 or 100 to distal graft assembly 20. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the proximal graft assembly 10 can be secured to the distal graft assembly 20 using surgical staples, suturing, gluing, or other methods. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

As described above in connection with FIGS. 2 and 4, it is contemplated that the distal graft assembly 20 can be used with a standard vascular graft, not shown. The vascular graft is also secured to the wall 2 of the blood vessel 1 while in the anterior position using either a locking device as described below, or a self-expanding stent 30. Next, the vascular graft is fitted and secured to the distal graft assembly 20, as described above.

FIGS. 8 and 9 show the proximal graft assembly 10 or 100 at the proximal end of the blood vessel 1.
Figure 5 shows a proximal attachment assembly 150 according to the invention for securing a.
For example, as shown in FIGS. 5, 6, 8 and 9, in accordance with a preferred embodiment of the present invention, in connection with securing proximal graft assembly 10 or 100 to vessel wall 2, Preferably, an attachment assembly 150 is used. The proximal attachment assembly 150 includes a cuff attachment section 151.
And a blood vessel attachment part 152. Attachment cuff 12 or 121
Is fixed to the cuff attachment part 151 by sewing, for example. Next, the blood vessel attachment part 151 is fixed to the blood vessel 1 by using, for example, a fastening device or a self-expanding stent 30 and a fastening device as necessary. Alternatively, the proximal attachment assembly 150 is fitted and secured in the blood vessel 1 in the manner described above in connection with FIGS. The cuff attachment portion 151 and the attachment cuff 12 or 121 interact in such a way that the proximal graft assembly 10 or 100 is not affected by dilation of the neck of the blood vessel 1 after the surgical procedure.

Another embodiment of a repair graft according to the present invention is disclosed in FIGS. 10 and 12 utilize a pair of distal graft assemblies 20 secured at the proximal and distal ends of the vessel. The proximal graft assembly 1000 includes:
It forms a passage in the blood vessel 1 and interconnects with the distal graft assembly 20. As described above, the proximal graft assembly 1000 is secured to the attachment leg 22 of the distal graft assembly 20 using a self-expanding stent 30 or other suitable fastening means. Attachment leg 22 includes proximal graft assembly 10.
00 can be inserted. Alternatively, the proximal graft assembly 1000 can be inserted into the attachment leg 22, as shown in FIG.

The repair graft described above facilitates the repair of blood vessels in a manner that is independent of shape and size. This is particularly useful in that the post-operative aortic neck generally increases in size in about 12 months. The repair graft described above accommodates such expansion without allowing leakage or dislocation of the graft. The attachment cuff is adaptable to changes in the size of the abdominal aortic neck. Further, use of the distal graft assembly 20 allows for a distal attachment that obviates the need for an iliac / femoral attachment.

According to the present invention, the details and assembly of the graft in the abdominal aorta create a situation where the locking device is positioned outside the bloodstream and is therefore not the focus of thrombus generation.
The distal and proximal bifurcated grafts according to the present invention can be strategically marked with a radiolucent material that allows their visual tracking and accurate placement before anchoring in the aorta. Platinum oxide freezes / bands are vacuum deposited, photo-deposited, or glued to the graft material at the tube end (proximal graft), tube end / halo rearrangement (distal graft), and around the halo. Other inert metals, such as gold, molybdenum and titanium, can also be used effectively to make the material. The radiolucent wire or metal fiber is knitted or incorporated into the graft--not knitted or incorporated with the coating method described above. The details of the titanium or polymer (suitably permeable) rings discussed above are also radiolucent.

In the embodiments described above, the proximal graft assemblies 10, 100 and 100
O, distal graft assembly and proximal attachment assembly 150
Is preferably formed from a cross-woven non-crimp polyester, Gore-Tex® or equivalent biocompatible material. It will be apparent to those skilled in the art that various changes and modifications can be made in the structure and construction of the present invention without departing from the scope or spirit of the invention. For example, in the above embodiments, a variety of other suitable materials, such as Dacron® or other biocompatible materials, can be used to form the repair graft. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

The attachment cuff may include a peripherally located ring. The ring can include a metal spring wound into a cuffed hole in a polymeric spring molded directly into the cuff. The ring is used to keep the cuff fully expanded during the process of attaching the graft to the vessel wall. This ring has no negative impact on the insertion process, as described below.

As with the other grafting methods, the proximal graft assemblies 10, 10 according to the invention
A value of 0 or 1000 requires an attachment to the wall 2 of the blood vessel. often,
It is necessary to attach the distal end of the graft into a material that is always calcified and therefore difficult to penetrate. When combined with the absence of a distal neck in the blood vessel, the presence of plaque forces others to facilitate the use of a bifurcated graft in which the graft limb is secured by a stent in the common iliac or femoral artery. This procedure can potentially damage the femoral artery. In addition, the presence of a graft or stent in the iliac or femoral arteries potentially limits blood flow in the blood vessel. This is useless when utilizing the repair graft according to the invention.

[0079] Reference will now be made in detail to a preferred embodiment of a device according to the present invention for facilitating repair of an abdominal aortic aneurysm using the graft described above. Examples of endovascular endoscope-based systems are shown in FIGS.

The repair device 5 includes a housing 200 for receiving the visualization device 6 and the penetrating device 7 alternately, as shown in FIG. However, the inventor of the present invention uses the visualization device 6
And the penetrating device 7 are considered to be integrated into a single assembly within the repair device 5. The housing 200 has a hollow structure, as shown in FIG. 14, which allows for the insertion of the visualization device 6 or the penetrating device 7 described in detail below. The housing 200 is divided into two main parts, a static housing part 210 and a flexible housing part 220. The housing 200 has a sufficient length and extends from the repair site in the blood vessel 1 through a suitable or selected artery to a point outside the patient.

The housing 200 has a hollow interior 211 that allows the passage of one of the interchangeable devices 6 and 7. The inner surface of the hollow interior 211 includes anti-rotation means 212 for properly orienting the interchangeable devices 6 and 7 within the housing 200. In a preferred embodiment, the anti-rotation means 212 is threaded and extends along the inner surface of the hollow interior 211, as shown in FIG. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the anti-rotation means 211 described above can be located at different radial positions in the housing and can prevent rotation of the interchangeable devices 6 and 7 in the housing 200, such as threads, grooves, There may be multiple grooves or other devices. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

As shown in FIG. 13 and FIG. 17,
Device guiding means 214 for guiding the repair device 5 in the blood vessel 1 during use. The guidance means 214 is preferably a passage or lumen extending into the housing through the static portion 210. The guidance means 160 cooperates with the guidance means 214 to guide the device 5 in use. Preferably, the guiding means 160 is a guiding wire that can extend from the femoral artery to the axillary artery. In a preferred embodiment, the guide wire 160 is a filament (eg, stainless steel, titanium or Kevlar).
(Registered trademark). However, as will be apparent to those skilled in the art, a variety of other materials having similar properties of physical integrity, high strength, flexibility, and minimal thermal expansion are used to form guide wire 160. be able to. The guide wire 160 protrudes from the flexible housing part 220 through the device 226 of the housing 200, as shown in FIG.

The housing 200 also includes device operating means 215 to assist in manipulating and orienting the device 5 within the blood vessel 1 during a repair operation. The operating means 215 includes the static housing part 210
It preferably includes at least one passage extending through the housing wall through and terminating in the flexible housing portion 220. The operating means 170 cooperates with the operating means 215 to guide the device 5 during use. The operating means 170 preferably includes at least one guide wire that can extend through the housing 200 from outside the patient. The guide wire 170 extends through the operating means 215. In a preferred embodiment, the guide wire 170 is a filament (eg, stainless steel, titanium or Kevlar®), but as will be apparent to those skilled in the art, physical integrity, high strength, flexibility, and A variety of other materials having similar properties of minimal thermal expansion can be used to form the guidewire 170.

The guide wire 170 of the operating means 170 terminates in the flexible housing part 220.
Operation of the operating means 170 results in engagement of the ends of the flexible housing portion 220. Guide wire 170 maintains flexible housing portion 220 in the engaged position, as shown in FIGS. 13 and 16, and visualization device 6 and penetrating device 7 change the orientation of repair device 5 with respect to the surgical site. Can be replaced without having to.

The wall of the static housing part 210 has an outer surface made of silicone and Tefl
on.RTM. on. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the walls of the housing may be formed from a suitable polymer (eg, Pebax®) or other materials having similar properties including, but not limited to, biocompatibility, flexural strength, and low coefficient of friction. it can. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

The flexible housing part 220 can be formed in a similar manner as the static housing part 210. For example, the housing may have an outer surface formed of silicone and a T
Includes an inner surface formed from eflon®. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the backing can be formed from a suitable polymer or other material having similar properties including, but not limited to, biocompatibility, flexural strength, low coefficient of friction. Alternatively, the flexible housing part 2
20 includes a coil metal spring outer casing 224 surrounding the backing.
This backing may be formed from Teflon®. The coil metal spring outer casing 224 may be formed from biocompatible stainless steel or titanium. The outer spring casing 224 is connected to the flexible housing 22.
It is not necessary to extend along the entire length of zero. Rather, the outer spring casing 224 can be located along a portion of the flexible housing portion 220 that is subjected to bending. However, it is contemplated that an external spring casing extending along the entire length of the flexible housing portion 220 is within the scope of the present invention.

The flexible housing part 220 and the static housing part 210 are manufactured as separate components. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the static housing portion 210 and the flexible housing portion 220 may be formed as a single component. In a preferred embodiment, the static housing 21
0 is permanently fixed to the flexible housing part 220. However, the housing part 2
10 and 220 may be removably attached.

FIGS. 18 and 19 show another repair device 500 for alternately receiving a visualization device 6 and a penetrating device 7 according to another embodiment of the invention. The repair device 500 includes a housing 2000 for receiving the visualization device 6 and the penetrating device 7 alternately. Housing 2
000 is flexible, has a sufficient length, and extends from the repair site in blood vessel 1 through a suitable artery to a point outside the patient.

The housing 2000 is hollow and allows the passage of one of the interchangeable devices 6 or 7, as described for the housing 200. The housing 2000
It includes at least one guiding means 2140 arranged outside the housing 2000 for guiding the repair device 500 in the blood vessel 1 in use. The guide means 2140 is preferably a passage extending along the exterior of the housing wall to a point adjacent the distal end 2001 of the housing 2000.

The guide wire 160 extends into the guide means 2140. A guide wire 160 extends from the end of the guide means 2140 and, as shown in FIGS.
00 at the distal end 2001. By adjusting the guide wire 160, the position of the repair device 500 in the blood vessel 1 is operated. The arrangement described above results in a repair device 50 in the blood vessel 1.
It allows a wide range of engagements of zero.

An additional guide wire 161 is secured to the distal end 2001 of the housing 2000. Guide wire 161 extends through vessel 1 and the appropriate artery to allow adjustment of the position of repair device 500 within the vessel.

FIG. 20 shows another repair device 5000 for accommodating the visualization device 6 and the penetrating device 7 alternately according to another embodiment of the present invention. The repair device 5000 includes a flexible hollow housing 2010, has a sufficient length, and extends from the repair site in the blood vessel 1 through appropriate arteries to a point outside.

The housing 2010 includes at least one guide wire 162 extending along the outside of the housing 2010, as shown in FIG. Housing 2010
Includes an inflatable portion 2011 disposed adjacent the distal end 2001. Inflation of the inflatable portion 2011 allows for engagement of the repair device 5000 within the blood vessel 1. A passage, not shown, extends into the housing 2010 and allows the inflatable portion 2011 to expand with a suitable liquid or air, such as saline or a suitable liquid polymer. An additional guide 161 is secured to the distal end 2001 of the housing 2010. A guide 161 extends through the blood vessel 1 and the appropriate artery to allow for adjustment of the position of the repair device within the blood vessel.

Another embodiment of the repair device is shown in FIGS. As in the previous embodiment, the repair device 3000 includes a housing 3100 that alternately houses one of the visualization device 6 and the penetrating device 7. However, it is included in the present invention that the visualization device and the penetrating device may be integrated into a single assembly located within the repair device.

The repair device 3000 shown in FIG. 60 includes a multi-lumen housing 3100. The housing 3100 has a band end assembly 3300 located at the proximal end of the housing and a device tip assembly 3400 located around the distal end. As shown in FIGS. 60 and 61, the positioning assembly 3200 is
It is located around 100 distal ends.

Next, the housing 3100 of the repair device 3000 will be described in detail with reference to FIG. Housing 3100 includes a central channel, lumen or passageway 3110. The visualization device 6 and the penetrating device 7 are alternately housed in the central path 3110. Central route 31
10 is a fluorinated polymer core 3120 from which the polyurethane layer 3130 is projected
Formed from a multi-layer assembly comprising: Further, a multi-stranded wire braid assembly 3140 is wrapped around the polyurethane layer 3130. A multi-lumen polymer assembly 3150 is formed into a blade assembly 3140. Polymer assembly 3150 can be molded from Pebax or other similar materials.

The structure of this embodiment and the embodiments described above offers a number of advantages. Route 3
The inner surface of housing 3100 forming 110 is lubricious and has a low coefficient of friction.
This facilitates passage of both the penetrating device 7 and the visualization device 6 through the inner lumen. The tubular structure is tight and compressible. The blade assembly 3140 shown in FIG.
Provides 100 improved kink resistance, torque capability and flexibility. Further, the location of the blade assembly 3140 within the multi-lumen polymer assembly 3150 allows for non-destructive access to the peripheral lumen in the multi-lumen assembly 3150, as shown in FIG. Housing 3100 is strong and has a low coefficient of expansion. Multi-lumen assembly 3150 further provides a thermoplastic outer surface to which positioning assembly 3200 is apt to adhere.

The position of the second lumen within the polymer assembly 3150 can be changed.
The placement of the lumen within the polymer core 3120 is considered to be well within the scope of the present invention.

The repair device 3000 incorporates at least one guide line 3170. Guidance wire 3170 can be formed of SPECTRA® or KEVLAR® fiber. These fibers have several advantages, including but not limited to a lubricated tubular structure, tightness, low coefficient of expansion and toughness. However, other materials can be used in connection with forming the guide wire, including but not limited to metal wires. Guidance line 3170 passes through lumen 3171 in multi-lumen assembly 3150 in housing 3100. Guidance line 3170
Extends from the ferrule end assembly 3300 through the housing 3100, FIG.
As shown at 0, the device tip assembly 3400 to the repair assembly 300
Exit 0. Guidance line 3170 may pass freely through housing 3100 or may be securely fastened therein.

The housing 3100 also incorporates at least one engaging wire 3160. At least one wire 3160 can be formed of stainless steel with a biocompatible lubricious polymer coating. The wire 3160 passes through a second lumen 3161 in the housing 3100 shown in FIG. At least one engagement wire 3160 extends from the tension collar 3310 of the repair device controller (not shown) through the band end assembly 3300 and housing 3100 shown in FIG. At a predetermined distance from the band end assembly 3300, the wire 3160
Exits the housing 3100 through the orifice shown in FIGS.
Connect to device assembly 3400. Manipulation of wire 3160 causes an arcuate deflection of housing 3100 at its distal end.

An inflation port 3180 is located adjacent the proximal end of housing 3100. Inflation port 3180 allows for inflation of positioning assembly 3200 within blood vessel 1. An inflation port 3180 is provided in housing 3 adjacent the repair assembly controller.
It also provides 100 strain relief. The positioning assembly 3200 is shown in FIGS.
Although described in connection with the embodiment shown in FIG. 2, the use of a positioning assembly 3200 according to any of the embodiments described above is considered to be well within the scope of the present invention. Housing 3100 includes inflation path 31 within multi-lumen assembly 3150.
81 is incorporated. Inflation path 3181 is connected to port 3180 to allow for inflation / deflation of eccentric locating assembly 3200. Positioning assembly 32
00 is preferably formed of silicon and, when inflated, positioning assembly 3
200 is positioned on the housing 3100 to securely hold the repair device 3000 against the blood vessel 1.

The band end assembly 3300 is located at the proximal end of the repair assembly 3000. Preferably, the band end assembly 3300 is made of a biocompatible material, such as metal, plastic, or ceramic. Preferably, the band end assembly 3300 is bent into the blade layer 3140 of the housing 3100.

The device tip assembly 3400 is made of stainless steel or other suitable biocompatible material and provides the distal end of the repair assembly 3000. The device tip assembly 3400 is coupled to the blade layer 3140. Guidance line 3170 extends from multi-lumen assembly 3150 to tip assembly 340 as shown in FIG.
Go into the appropriate details in 0. The device tip assembly 3400 includes the repair device 30
It includes an electromechanical assembly that controls the delivery of the surgical locking device from the penetrating device 7 when positioned within the 00.

The overall dimensions of the various embodiments of the repair device described above allow for axillary access not previously possible. In this regard, the repair device used in connection with the visualization device 6 or the penetrating device 7 can be used in other surgical procedures not previously intended. The size of the device allows for insertion through the introducer sheath 900 described below. The device can also be introduced percutaneously into a blood vessel. This procedure is less invasive and / or invasive than other surgical procedures.

Vascular Endoscope (IVA) Visualization Device Next, a preferred embodiment of the interchangeable devices 6 and 7 for use with the repair device 5 according to the invention for facilitating repair of abdominal aortic aneurysms See details. Next, the visualization device 6 will be described with reference to FIGS.

A visualization device 6 is inserted into the repair device 5 and illuminates the assisting abdominal aorta to enable real-time direct observation and diagnosis and repair of aneurysms. The visualization device 6 is an endoscopic endoscope-based system that includes a housing 300 for housing various illumination and viewing components. The housing 300 is preferably formed as a conduit sized to slide into the housing 200. In a preferred embodiment, the housing 300 is an extrusion of silicone, Teflon®, or a polymer or other material having similar properties.

The housing 300 extends through the hollow interior 211 of the housing 200.
Housing 300 may include orientation means 310 for orienting visualization device 6 within housing 200. The orienting means 310 is a rotation preventing means 2
Work with 12. In a preferred embodiment, the directing means 310 comprises the housing 3
The channel extends along the outer surface of the 00. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the directing means 310 described above may be located at different radial positions within the housing 300. Orienting means 310
May be a thread, a groove, a plurality of grooves, or other devices that are complementary to anti-rotation means 212 that prevent rotation of the visualization device 6 within the housing 200.

As shown in FIG. 15, the housing 300 has a plurality of passages 3 formed therein.
11, 312, 313, 314, and 315. Passages 311, 312, 3
13, 314 and 315 extend along the entire length of the housing 300. A central passage 311 is provided for passage of an optical observation means 320 for observing the abdominal aorta. In a preferred embodiment, the optical viewing means 320 is a fiber optic system. This system incorporates a fiber optic bundle. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the optical viewing device 320 described above may be a flexible optical system sized for use in surgical applications. The optical observation means 320 enables real-time direct observation of the repair site in the blood vessel 1. The optical viewing means 320 can be connected to a video camera and monitor (not shown) that allow the surgeon to view the repair site. The images are stored and can be recalled as needed, either by a video printer or a video cassette recorder. The penetrating device 7 is arranged at the same position as the visualization device 6. The penetrating device 7 incorporates a radiolucent marker that indicates the exact location of the penetrating device 7 on the monitor. This allows the surgeon to monitor and track the adjustment of the repair device 5.

Peripheral irradiation passages 312 and 313 are provided for the passage of irradiation means 330 for irradiating the abdominal aorta for observation by optical observation means 320. In a preferred embodiment, the illumination means 330 is a fiber optic system including a fiber optic bundle. However, it will be apparent to one skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the illumination means 330 described above may be any system sized for use in surgical applications and capable of illumination within the aorta. Although a pair of passages are illuminated, it is conceivable that a single illumination passage provides sufficient illumination. Also, more than one passage can be provided.

A peripheral liquid inflow passage 314 and a peripheral liquid outflow passage 315 are provided for passage of the liquid lens medium to and from the visualization tip 340. The peripheral liquid inflow passage 314 provides an optically clear flow of the liquid lens medium from the visualization tip 340 at a location in front of the optical viewing means 320. Control means (not shown) may be incorporated into passageway 314 to control the flow and velocity of the liquid lens medium to visualization tip 340. The control means may be a valve or other suitable flow control device. The control means controls the optically clear liquid lens such that the blood and liquid lenses in the arterial cavity are pressure stable. As a result, generally, blood in the aorta is temporarily deflected by the liquid lens medium and moves to a point adjacent to the portion of the wall 2 observed by the optical observation means 320. Injection of the liquid lens medium dilutes the blood to the appropriate clarity of the intermediate surgical site and eliminates the blood between the visualization tip 340 and the surgical site on the wall 2. Thus, the surgeon can clearly observe the wall 2 through the optical observation means 320. In a preferred embodiment, the fluid lens is a transparent liquid that allows observation of the wall 2. The liquid lens may be saline. Preferably, the solution is used for a single application (ie, not recycled). CO2
Other media, such as gasses and Green Cross liquid fluorocarbons, are contemplated within the scope of the present invention. The peripheral liquid outflow passage 315 acts as a return duct for the liquid lens medium in the aorta. Alternatively, the liquid lens medium can be further filtered using suitable filtration means and recirculated using the pumping means through the surrounding liquid inflow passage 314.

In a preferred embodiment, the visualization device 6 includes an introducer sheath device 90 described below.
It is conceivable that it is used in connection with 0. The introducer sheath device 900 and particularly the positioning assembly 920 allow for isolation of portions of the blood vessel during a repair procedure.
In particular, the positioning assembly 920 in the common iliac and femoral arteries allows for control of blood in the blood vessels. With this device, it is possible to easily deflect the blood from the observation site together with the flow of the liquid lens medium from the liquid inflow passage 314.

The visualization tip 340 is securely attached to the end of the housing 300 in a liquid tight manner. The tip 340 is snapped or permanently attached to the housing 300. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the visualization tip 340 described above can be secured to the housing 300 by means other than the snaps and permanent attachments described above. Visualization tip 340 can be formed by injection molding or other suitable manufacturing method of silicone or similar polymer.

The visualization tip 340 includes openings 341, 342, 343, 344, and 345 corresponding to passages 311, 312, 313, 314, and 315, respectively. Opening 341 includes a lens disposed therein that facilitates observation of wall 2 by optical viewing means 320. The openings 342 and 343 include a window therein, whereby light from the illumination means 330 passes through the window and illuminates the wall 2, but it is not necessary. Openings 344 and 345 act as gates for peripheral liquid inflow passage 314 and peripheral liquid outflow passage 315. The opening 344 is tapered inward so that the inside diameter of the opening adjacent the inflow passage 314 is larger than the diameter on the outer surface of the tip 340 to concentrate the flow of the liquid lens medium from the liquid inflow passage 314. ing. The opening 345 may be tapered outward such that the inner diameter of the opening adjacent the inflow passage 315 is smaller than the diameter on the outer surface of the tip 340. Tip 340 is considered optional.

Next, the penetrating device 7 will be described with reference to FIGS. 17 to 25. The penetrating device 7 can be inserted into the repair device 5, 500, 5000, as shown in FIGS. 17 to 20, to secure the repair graft to the vessel wall 2. The penetrating device 7 includes several types of components including a penetrating means 420, a second penetrating means 430, a tracking means 440 and an inserting means 450. The penetrating device 7 includes a penetrating means 420 and a second penetrating means 430.
41 for housing the tracking means 440 and the insertion means 450
Contains 0. In a preferred embodiment, the housing 410 has a three-limbed shape surrounded by thin walls as shown in FIGS. 19, 21 and 22. In a preferred embodiment with increased flexibility, the housing 410 is positioned within the repair device 5 such that two of the three limbs of the housing 410 are spaced from the side of the housing 200 containing the guidewire 160. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the housing 410 described above may have more than two limbs. Alternatively, housing 410 may be cylindrical with a plurality of inwardly projecting limbs. Another configuration of the housing 4100 is shown in FIGS. Housing 4100 includes a central passageway 4110 containing a penetration means 420. Additional passages 4210 and 4130 are provided for other components such as second penetration means, tracking means and insertion means.

The housing 410 is preferably formed by injection molding of silicone, Teflon®, or a polymer having similar properties. Housing 410
Have a plurality of passages 411, 412, 4 formed therein, as shown in FIG.
13 and 414. Another arrangement is shown in FIG. Passages 411, 4
12, 413 and 414 extend along the entire length of the housing means 410.
A first passage 411 is provided for passage of the penetrating means 420. A penetrating means 420 is provided to create a treatment-specific hole in the wall 2 of the abdominal aorta for securing the graft thereto with a suitable locking device as described below. The penetrating means 420 penetrates the potentially calcifying vascular wall 2 and secures the repair graft to the wall 2. Penetration means 42
0 is a laser penetrating device, a piezoelectric penetrating device or a high radio frequency
OLI). However, the inventor of the present invention states that CO2 penetration,
Other penetration means, including but not limited to microelectromechanical systems, and intraluminal suturing are contemplated as being within the scope of the present invention. Laser penetrator 420 is preferably an IR fiber optic based system that uses laser energy to create treatment-specific holes in aortic wall 2. The size of the fused silica / quartz fiber utilized ranges from 200 to 600 microns. The fiber also has a low O
H polyamide may be included. Suitable lasers include an ultrasonic optical laser having a wavelength of about 1.35 μm, and holmium Ya having a wavelength of about 2.1 μm.
g, including but not limited to lasers. Depending on the selected wavelength, the path 411
Transfer of laser energy through the fiber. The laser fiber is in direct contact with the surgical site such that the fiber projects from the end of housing 410. Using the penetrating means 420 and the second penetrating means 430, a single or three
It is believed that a fork pattern is created.

The piercing device is preferably a catheter-based system that utilizes acoustic vibrations to create treatment-specific suture holes that assist in graft / tissue attachment. Piezoelectric piercing devices add an "acoustic wave" effect to create holes in the graft and vessel wall. In this variation, the passageway 411 preferably contains a rod or a tubular superelastic titanium catheter that allows the transfer of energy through the often tortuous blood vessel to the surgical site. The catheter is in direct contact with the surgical site and the catheter is
It projects into a treatment-specific hole formed from the end of the zero. The second penetrating means 430 creates one or more temporary holes. The piezoelectric device is 20KH
Preferably, it operates at a frequency of z. Other frequencies, both high and low, are considered to be within the scope of the present invention. The first penetrating means 420 is such that the fastening device is the first penetrating means 4.
Coaxial with the locking device for insertion through the treatment-specific hole created by 20.

A second passage 412 is provided for passing through the second penetration means 430. A second penetrating means 430 is also provided for creating one or more temporary holes in the vessel wall 2 in a manner similar to the first penetrating means 420. Similarly, the second penetrating means 430
As described above with respect to the penetrating means 420, it may be either a laser penetrating device or a piezoelectric penetrating device. The second penetrating means 430 is such that the fastening device is the first penetrating means 4.
Securing the penetrating device 7 while being inserted into the treatment-specific hole formed by 20;
Used to orient. After the second penetration means 430 is removed, the temporary holes are sealed with coagulating blood.

A passage 413 is provided in the housing 410 for passage of the insertion means 450 described below.
Provided within. A passage 414 is provided for housing means 4 for passage of tracking means 440.
Provided within 10. In a preferred embodiment, the tracking means 440 is a radiolucent marker and is used for the purpose of locating the penetrating device 7 in the image on the monitor. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the tracking means 440 described above may be a chip tracker or a fiber optic aiming beam.

An insertion means 450 for fixing the repair graft to the wall 2 during repair of the aneurysm is shown in FIG.
No. 4 will be described. The insertion means 450 comprises a means for penetrating the repair graft and the wall 2.
Preferably, it includes a mechanism for driving individual locking devices from the locking device cartridge 460 shown in FIGS. 17 and 23 into and through the treatment-specific holes created by 20. The locking device cartridge 460 is capable of holding a plurality of locking devices such that one or more locking devices move continuously from the cartridge 460 and secure the repair graft to the abdominal aortic wall 2. . The locking device cartridge 460 is preferably detachably connected to the housing 410. The locking device cartridge 460 is a hollow housing as shown in FIG.
N) Preferably injection molded HOPE or liquid crystal manufactured by RAP of the state. Penetration means 420 and 430, tracking means 440 and insertion means 450 are suitably housed inside cartridge structure 460. The cartridge 460 is disposed around the housing 410.

The insertion means 450 shown in FIG. 24 includes a driving means 451 for driving a fastening device for fixing the repair graft to the blood vessel wall 2. Gear 452 and fastening device advancing means 45
3 is located in the opening 454 of the housing 410. In a preferred embodiment, gear 452 is a worm gear. However, other suitable gear assemblies are contemplated within the scope of the present invention. The gear 452 is connected to the driving means 451. The locking device advancement means 453 interacts with the gear 452 to advance the locking device,
Fix the repair graft to In a preferred embodiment, the fastener advancement means 453 is an internal geared drive plate assembly. The drive plate assembly allows for limited angular adjustment. The operation of the insertion means 450 is performed by the operation of the control device and the fastening device advancing means 453 is advanced, and the fastening device cartridge 460 is operated.
The locking device is controlled by a control device (not shown) so as to eject the locking device.
Alternatively, the insertion means 450 can be manually operated. The insertion means 450 is used, for example, in the embodiment shown in FIG.

Another embodiment of the insertion means 4500 is shown in FIG. An insertion cartridge 4510 is secured to the distal end of the repair device 5. The insertion cartridge 4510 can also be snap-mounted to the housing 200. The insertion cartridge 4510 includes a cavity 4511. Spring means 4520 is located within cavity 4511. Locking device cartridge 460 is also located within cavity 4511. Opening 45
30 is located at one end of the insertion housing 4510. The housing 410 of the penetrating device 7 typically prevents the spring means 4520 from driving the locking device through the opening 4530. The insertion means 4500 connects the housing 410 with the opening 4530.
And a retraction means 4540 for retracting the locking device from the treatment-specific hole created by the first penetrating means 420. Retraction means 4540 may be a cable that acts to retract housing 410 from opening 4530. With the release of the retraction means 4540, the housing 410 is opened.
Return to a position adjacent to and prevent subsequent firing of the locking device.

Intravascular Ultrasound (IVUS) Repair System Reference will now be made in detail to a preferred embodiment of a device according to the present invention for facilitating repair of an abdominal aortic aneurysm using the graft described above. Examples of an intravascular ultrasound-based system are shown in FIGS.

The repair device 50 includes a housing 800. Housing 800 includes a large guide wire section 810, a spacer section 820, and a small guide wire section 830, the cross sections of which are shown in FIG.

Located within the housing 800 is the repair device 50 in the blood vessel 1 during use.
Device guiding means 214 for guiding the user. The guide means 214 is preferably a passage or lumen extending the length of the housing 800 through the large guide wire section 810, the spacer section 820, and the small guide wire section 830. Guiding means 16
0 cooperates with the guidance means 214 to guide the device 50 in use. Preferably, the guiding means 160 is a guiding wire that can extend from the femoral artery to the axillary artery. In a preferred embodiment, guide wire 160 is a filament (eg, stainless steel, titanium or Kevlar® cable). However, it will be apparent to those skilled in the art that various other materials having similar properties of physical integrity, high strength, flexibility, and minimal thermal expansion may be used to guide wire 160
Can be formed.

The housing 800 also includes device operating means 215 to assist in manipulating and orienting the penetrating device 700 in the blood vessel 1 during a repair operation. The operating means 215 includes a housing 810
Preferably, it includes at least one passage extending therein. The operating means 215 is paired with an auxiliary passage formed in the housing 710. The operating means 170 is the operating means 21
5 and guides the device 50 in use. The operating means 170 preferably includes at least one guide wire that can extend through the housings 810 and 710 from outside the patient. The guide wire 170 extends through the operating means 215. In a preferred embodiment, guidewire 170 is a superelastic filament. However, as will be apparent to those skilled in the art, a variety of other materials having similar properties of physical integrity, high strength, flexibility, and minimal thermal expansion are used to form guide wire 170. be able to.

The operation of the operating means 170 results in the engagement of the end of the housing 710. Guide wire 170 maintains housing 710 in the engaged position during the repair operation, as shown in FIG.

Next, the penetrating device 700 will be described with reference to FIGS. 26 to 29. The penetrating device 700 includes several types of components including a penetrating means 420, a second penetrating means 430, a tracking means 440, and an inserting means 450. The penetrating device 700 includes a penetrating means 420, a second
Includes a housing 710 for housing the penetrating means 430, tracking means 440 and insertion means 450. In a preferred embodiment, the housing 410 is configured as shown in FIG.
27, and have a shape with three limbs surrounded by thin walls as shown in FIGS. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention.

The housing 710 is preferably formed by injection molding of silicone, Teflon®, or a polymer having similar properties. Housing 710
Have a plurality of passages 711, 712, 7 formed therein, as shown in FIG.
13, 714 and 715. Passages 711, 712, 713, 714 and 715 extend along the entire length of housing means 710. A first passage 711 is provided for passage of the penetrating means 420. A penetrating means 420 is provided to create a treatment-specific hole in the wall 2 of the abdominal aorta for securing the graft thereto with a suitable locking device as described below. The penetrating means 420 penetrates the potentially calcifying vessel wall 2 and secures the repair graft to the wall 2, as described above for the endoscope-based system. The penetrating means 420 may be either a laser penetrating device or a piezoelectric penetrating device.

A second passage 712 is provided for passing through the second penetrating means 430. A second penetration means 430 is also provided for opening one or more openings in the vessel wall 2 in a manner similar to the first penetration means 420, as described above.

A passage 713 is provided in the housing 710 for passage of the insertion means 450. A passage 714 is provided in the housing means 710 for passage of the guide wire 170. A passage 715 is provided for tracking means 440. The insertion means 450 drives a separate locking device from the locking device cartridge 470 shown in FIGS. 26 and 27 into and through the treatment-specific hole created by the repair graft and the penetration means 420 of the wall 2. Preferably, it includes a mechanism. The locking device cartridge 470 is capable of holding multiple locking devices such that one or more locking devices move continuously from the cartridge 470 and secure the repair graft to the abdominal aortic wall 2. . It is preferable that the locking device cartridge 470 is detachably connected to the housing 710. The locking device cartridge 470 has a hollow housing 471 as shown in FIG. Penetrating means 420 and 430, and arrangement /
The locking means 450 is suitably housed inside the cartridge structure 460. The cartridge structure 470 and associated locking device are complementary to the spacer portion 820 of the housing 800 such that the penetrating device 700 has a smooth shape as shown in FIG.

A visualization device 600 for observing the abdominal aorta to repair an aneurysm is located in the housing 800 adjacent to the small guide wire 830. The visualization device 600 includes, for example, a housing 601 for housing the radial scanning components (Endonics of Rancho Cordova, Inc.)
An intravascular ultrasound (IVUS) based system manufactured by dosonics of Rancho Cordova, CA. Housing 610 includes scanning window 602, but this is not critical to the effective operation of visualization device 600. The visualization device includes a scanning catheter positioned within the housing 601 to scan a region of the abdominal aorta. The housing 601 is an extruded piece of silicone, Teflon® or a polymer or other material having similar properties. The scanning catheter extends through a small guidewire section 830 of the housing 800. The scanning catheter produces an image of the restoration that can be viewed on an external monitor, not shown.

The housing 800 includes transitions 801 and 802 located at opposite ends of the penetrating device 700.
To provide a smooth shape to the repair device 50 as shown in FIG.

Locking device Next, the locking device according to the invention for fixing the attachment device 20 to the distal end of the blood vessel 1 according to the invention, as shown in FIGS. 31 to 41, 49 to 53 and 55 to 59. Reference is made to details of an embodiment of the device. Although the locking device has been described with respect to repairing vascular aneurysms, the use of the locking device in other surgical procedures as an alternative to suturing is considered to be within the scope of the present invention.

FIGS. 30 and 31 show a locking device 510 according to an embodiment of the present invention. Fastening device 5
10 includes a pair of vertically bent locking legs 512 and 513. The locking device 510 is
As shown in FIG. 31, a fixing portion 514 is also included. The fastening device 510 is preferably formed of a wire-like material. The legs 512 and 513 are, as shown in FIG.
Temporarily redirected for storage of the locking device cartridge 460 and to allow attachment of the attachment device 20 to the wall 2. Legs 512 and 513
Are inserted through the attachment device 20 and the wall 2, the legs 512 and 513
As shown in FIG. 31, it returns to the vertically bent position during manufacturing. When the locking device 510 is in the locked position in the blood vessel, the anchor 514 is located on one side of the attachment device 20 and the wall 2 (intimal / graft) adjacent to the attachment device 20. The bent legs 512 and 513 are located on the opposite side of the attachment device 20 adjacent to the wall 2 and the wall 2 (adventitia). The fixing part 514 and the bent legs 512 and 513 are attached to the wall 2.
Then, a compressive force is applied to the attachment device 20 to securely fasten the attachment device 20 to the blood vessel 1.

The locking device 510 is preferably formed of stainless steel so that the legs 512 and 513 return to the bent position and secure the attachment device 20 to the wall 2. However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the locking device 510 may be formed of a material suitable for other treatments / performances, such as superelastic titanium or plastic having similar properties including, but not limited to, biocompatibility, elasticity, and flexural strength. it can. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

FIGS. 32 and 33 show a locking device 520 according to another embodiment of the present invention. The locking device 520 includes a pair of normally inclined locking legs 522 and 523. Fastening device 52
0 also includes the fixed part 524. Preferably, the fastening device 520 is also formed of a wire-like material. The securing portion 524 can be formed of at least one coil of a wire-like material (ie, a wound portion). The legs 522 and 523 are temporarily compressed, as shown in FIG. 32, for storage of the locking device cartridge 460 and to allow the attachment of the attachment device 20 to the wall 2. FIG. 30 and FIG.
32, when the legs 522 and 523 are inserted through the attachment device 20 and the wall 2, the legs 522 and 523 return to a vertically bent position, as shown in FIG. When the locking device 520 is in a locked position in a blood vessel,
The fixing portion 524 is arranged on one side of the wall 2 with the attachment device 20 adjacent to the attachment device 20. The inclined legs 522 and 523 are arranged on the attachment device 20 adjacent to the wall 2 and on the opposite side of the wall 2. Fixed part 524 and bent leg 522
And 523 apply a compressive force to the wall 2 and the attachment device 20 to securely fasten the attachment device 20 to the blood vessel 1.

FIGS. 34 and 35 show a locking device 530 according to another embodiment of the present invention. Locking device 530 is a spring-type locking device that can include a coil spring. The fastening device 530 is also formed of a wire-like material. The locking device 530 is shown in FIG.
As shown in FIG. The ends 531 and 532 of the wire-like material are preferably located at the same end of the fastening device 530, as shown in FIGS. 29, 30, and 34-36. Unlike the locking devices 510 and 520, the locking device 530 temporarily extends the storage in the locking device cartridge 535, as shown in FIGS. When the fastening device 530 is inserted through the attachment device 20 and the wall 2 using the insertion means 450 on the penetrating device 7 as shown in FIG. 44, the blood vessel 1 formed by the penetrating device 7 and the attachment device 20 The locking device 530 remains in the extended position until the insertion means 450 is removed from the treatment-specific hole 3 created in the wall 2 of the device. Next, the fastening device 530 is operated as shown in FIG.
As shown in (2), the folding position is secured. When the locking device 530 is in the locked position within the blood vessel 1, the ends 531 and 532 are located on one side of the attachment device 20 and the wall 2 adjacent to the attachment device 20, as shown in FIG. The remaining part of the locking device 530 is located on the attachment 20 adjacent to the wall 2 and on another side of the wall 2. The fastening device 530 applies a compressive force to the wall 2 and the attachment device 20 to securely fix the attachment device 20 to the blood vessel 1. Locking device 530 may be formed of stainless steel; a superelastic alloy, such as titanium; or other material suitable for the procedure / performance.

FIGS. 36, 37, 38, and 39 show a locking device 540 according to another embodiment of the present invention. The locking device 540 is a coil spring type locking device.
The locking device 540 includes a central portion 541 and semi-notched ends 542 and 543. The fastening device 540 is also formed by a coil spring using the above-described material. Preferably, the locking device 540 is formed of stainless steel or a superelastic alloy, for example, titanium. The locking device 540 is substantially linear when stored in a locking device cartridge, not shown, as shown in FIG. When the locking device 540 is inserted through the attachment device 20 and the wall 2, the locking device 540
Returns to its normal coiled configuration, as shown in FIG. The locking device 540 applies a compressive force to the wall 2 and the attachment device 20 to securely fix the attachment device 20 to the blood vessel 1, and as shown in FIGS. 38 and 39, one half-notched end 542 is attached to the attachment device 20. 20 and the other half-knotted end 543 will be placed adjacent to the wall 2 of the blood vessel 1. FIG. 28 shows a fastening device 540 wound in the axial direction. FIG. 40 shows the locking device 540 of FIG. 38 fixed to the wall 2. FIG. 39 shows a locking device 540 wound radially. FIG. 41 shows the locking device 540 of FIG. 39 fixed to the wall 2. The locking device 540 is called a coil spring type locking device wound in a coil shape. The coil spring constituting the fastening device is itself wound at the time of manufacture, and secures the configuration wound in the coil shape shown in FIGS. The locking device 540 is inserted through the attachment device 20 and the wall 2 using insertion means in the manner described above for the locking device 530.

FIGS. 49, 50 and 51 show a locking device 550 according to another embodiment of the invention.
Is shown. The locking device 550 is a coil spring type locking device formed of stainless steel or a superelastic alloy such as titanium or a material suitable for treatment / performance. When the locking device 550 is stored in a locking device cartridge (not shown),
As shown in FIG. 36, it is substantially linear.

The fastening device 550 is a coil spring-type fastening device wound in a coil shape wound in the fastening shape during manufacturing. The locking device 550 may include a plurality of coiled coil springs connected together. The embodiment shown in FIG. 49 includes two wrapped springs. The coil diameter and wire gauge for the design shown are about 1.016 cm (0.04 inch) and about 0.14 cm, respectively.
27 (0.005 inches). However, it is believed that the present invention is not limited to these dimensions. Deviated coil diameters of 1.016 cm (0.04 inches) or more and 1.016 cm (0.04 inches) or less (for example,
0.762 cm (such as 0.03 inches) is considered well within the scope of the present invention. The locking force of the locking device 550 can be adjusted to suit a particular purpose by varying the coil diameter, wire gauge, number of coils, and number of coil springs. The fastening device 550 is called a coiled coil spring because the coil spring is further wound into a shape suitable for fastening at the time of manufacture. The coiled coil springs including the locking device 550 are spot welded along at least one point along their length. Any suitable connection means used to maintain the springs of the coil wound in a fixed relationship with one another is within the scope of the invention and can be used instead of spot welding.

The locking device 550 includes a central portion 551 and underlap ends 552 and 553. Prior to insertion, the locking device 550 is temporarily straightened and placed around the insertion means. Locking device 550 is inserted through attachment device 20 and wall 2 using a process similar to that described above for locking device 530. After insertion, the core is removed and the locking device 550 returns to its normal coiled configuration, as shown in FIGS. The manufacturing configuration of the locking device 550 provides an innovative method for securing the attachment device. The ends 552 and 553 are
Underlap at point 554 providing a locking mechanism for 50. Fastening device 5
The underlap design of 50 makes the attachment device 2
Prevent 0 and wall 2.

FIGS. 52 and 53 illustrate a locking device 560 according to another embodiment of the present invention. Locking device 560 is a coil spring locking device formed of stainless steel or a superelastic alloy, such as titanium, or a material suitable for the procedure / performance. Fastening device 550
Similarly to the above, the fastening device 560 also uses a coil spring wound in a coil shape.
The locking device 560 includes a plurality of springs wound together. Locking device 56
0 may be a single coiled coil spring or a plurality of coiled coils wound together, as in the locking device 550 described above. The preferred embodiment is a 2nd embodiment, as shown in FIGS.
It includes coil springs 562 and 563 wound in a single coil. However, it is within the scope of the present invention that the locking device 560 includes two or more or less springs. The coil diameter and wire gauge for the design shown are approximately 1.016 cm (
0.04 inches) and about 0.127 cm (0.005 inches). The locking force of the locking device 560 can be adjusted to suit a particular purpose by varying the coil diameter, wire gauge, number of coils, and number of coil springs.

The locking device 560 includes a central portion 561 and ends 562, 563, 564, and 56.
5 is included. Prior to insertion, the locking device 560 is temporarily straightened and placed around the insertion means. The fastening device 560 is inserted through the attachment device 20 and the wall 2. After insertion, the insertion means is removed and the locking device 560 is unraveled, as shown in FIGS.
As shown in FIG. 3, the coiled springs 562 and 563 are returned to the manufacturing configuration. Springs 562 and 563 are spot welded together at at least one point along a central length 561. Spring ends 564, 56
5, 566 and 567 are not welded together and separate them when the insertion means is removed. Any suitable connecting means used to maintain the springs of the locking device 560 in a fixed relationship with each other are within the scope of the present invention and can be used in place of spot welding.

As described above, both locking devices 550 and 560 use coil springs wound in a coil with elastic / mechanical memory. After insertion through the attachment 20 and the wall 2, the coiled coil spring recalls its manufacturing form and returns to the form forming a fixation of the attachment device 20 on the wall 2.

The holdability of the coiled fastening device 570 is further enhanced by the embodiments of FIGS. 56-58. The fastening device 570 includes a fastening device 571 wound in a central coil shape. The locking device 570 further includes at least one short coiled insert 572. The insertion portion 572 wound in a coil shape is shown in FIGS.
As shown in FIG. 7, it is arranged adjacent to the end of the locking device 571. The short coiled insert 572 is wrapped at its end with a locking device 571 to create a unique head feature. Once the core on which the locking device 570 is temporarily located is removed, the locking device 570 returns to its configuration as manufactured. In this position, at least one coiled insert 572 separates from the host of locking device 571, creating dimensional interference and additional resistance to locking device disengagement. At least one coiled insert 572 is spot welded as shown at 573 to prevent complete separation from the locking device 571.

It is conceivable that the above-described coil spring fastening device may be a coil spring wound in either the axial direction or the radial direction. It is further contemplated that the coil spring may have a circular, rectangular, triangular or other cross-sectional configuration. It is contemplated that the locking devices described above may be surface treated to increase friction between the locking device and surrounding tissue. Further, a polymer material instead of a metal may be used. In addition to changing the coil diameter, wire gauge, number of coils, and number of coil springs to change the holding force of the coil fastening device wound in a coil shape, by changing the spring pitch between the coils, The performance of the locking device is also enhanced.

The locking device according to the invention is advanced to a surgical site either outside or within the penetrating assembly 7, as described above, by the activation of an advancement mechanism located remotely with respect to the patient. In order to minimize the complexity of the mechanism, it is necessary to closely control the length of the locking device beyond the mandrel. The compression of the lock is inherent in the design as it transitions from its "as-built" configuration to its "ready for insertion" configuration and is not expected in the design of the lock / lock advance mechanism. As long as it causes significant functional problems. The inventor of the fastening device of the present invention was able to remove the compression of the fastening device from the forward movement of the fastening device. According to one embodiment, the locking device transitions from its "as-built" configuration to its "ready for insertion" configuration, where "slack" created in the locking device is placed on the insertion assembly 450. It can be dimensioned to be removed when rolled. The inner diameter of the coil spring is equal to or slightly smaller than the insertion assembly 450 that is temporarily positioned over or over it. This “sizing” facilitates both pre-compression of the locking device on or within the penetrating assembly 7 and its uniform advancement to the surgical site.

The locking device can then be insert molded into gelatin or a similar dissolvable medium while in its “ready to insert” configuration. The resulting "
The "tubular" component is incompressible, allowing easy loading of the locking device outside or within the penetration means and uniform advancement to the subsequent surgical site to eventually supplement the graft / adventitia matrix. Promote both. The blood present dissolves the gelatin coating around and within the interstices of the locking device, allowing its "as-made" morphology and resumption of compressive attachment of the graft to the vessel wall.

Alternatively, the fastening device according to the invention can incorporate a dissolvable suture. As shown in FIG. 59, the fastening device 580 is provided with the individual coils 5 of the fastening device 580.
Incorporates a dissolvable suture 581 wound between 82. Providing a dissolvable suture material 581 may be used to secure the locking device 580 on the insertion assembly described above.
Prevents longitudinal compression of the Further, the use of suture allows for uniform advancement of the locking device 580 along the insertion and penetration assemblies during a surgical procedure.
It is believed that the use of the dissolvable suture 581 is not limited to the fastening device 580. Rather, the suture material 5 is meltable with a fastening device having at least a coiled spring portion, including but not limited to the embodiments described above.
Using 81 is considered well within the scope of the present invention.

However, it will be apparent to those skilled in the art that various modifications and variations can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. For example, the fastening means described above may be a pop rivet fastening device, a screw-type fastening device, and a fast-curing plastic extrusion, all of which are considered to be within the scope of the present invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.

A fastening device according to an embodiment of the present invention has been described in connection with aneurysm repair.
However, the invention is not limited to the repair of aneurysms, but rather, it is contemplated that the locking device according to the invention may be used in other surgical applications. For example, the tissue can be fixed to the tissue using a fastening device. Further, the use of the locking device is not limited to application within the patient, and the locking device can be used outside the body. further,
It is intended that non-surgical applications within the full range of use of the locking device be considered. For example, the materials can be secured together using a fastening device.

Introducer Sheath Device Reference is now made to a preferred embodiment of an introducer sheath device according to the present invention for use in repairing abdominal aortic aneurysms, an example of which is shown in FIGS. The introducer sheath device creates a protective passage through the vessel into which the graft and repair device are inserted. The introducer sheath device protects the artery from possible damage as the repair device or other device passes through the tortuous arterial passage during a surgical procedure.

Existing methods for repairing aneurysms use an introducer sheath device only in the femoral and common iliac arteries. Generally, the guidewire extends from the femoral artery incision to an occlusion balloon located in the proximal neck of the aorta at a point anterior to the abdominal aorta. Generally, others have 18 to 28 Fr. Access to the abdominal aorta is obtained by femoral or common iliac incision into which a diameter introducer sheath device is inserted.
The size of these devices also causes damage to the blood vessels through which they pass.

In contrast, the inventors of the present invention contemplate the use of one or more unique introducer sheath devices 900, as shown in FIG. Sheath 900 is introduced over the femoral / axillary guidewire. One introducer sheath device 900 extends from either the axillary or brachial incision to the proximal neck of blood vessel 1. Another introducer sheath 900 extends from the femoral incision to the distal neck or common iliac / distal aortic transition of the vessel. An introducer sheath device according to the present invention extending through axillary vessels and the femoral artery has a similar structure. However, the introducer sheath device extending through the axillary artery has a 9-12 Fr.
Small size and can travel through the arteriotomy / proximal aortic passage without problems. The small size allows access to the aorta via either the left brachial or axillary arteries, both of which are significantly smaller than the femoral or iliac arteries. This procedure was previously out of consideration but is now considered advantageous for these vascular procedures.

[0155] Each introducer sheath device 900 includes a housing 910 having a hollow interior 911 that allows passage of vascular grafts and other repair devices through the introducer sheath device to the vessel 1. Housing 910 preferably includes a plurality of lumens or passages formed therein. The repair device includes an opening 9 at the end of the housing 910.
Introduced through a twelve multiport introducer assembly. In a preferred embodiment, the housing 910 has an outer surface formed, for example, of silicone and
Co-extrusion surrounded by a thin wall with an inner surface formed of flon®. Alternatively, housing 910 can be formed of a suitable polymer having similar properties.

[0156] The introducer sheath device 900 also includes a positioning assembly 920 for maintaining the sheath 900 in the proper orientation within the blood vessel. In a preferred embodiment, positioning assembly 920 includes an inflatable cuff located at one end of housing 910. Positioning assembly 920 further includes an inflation device for inflatable cuff 921. The inflation device in the preferred embodiment includes a plurality of passages 923 formed in the wall of housing 910. A suitable liquid, such as saline, is supplied from an external source through passage 923 to fill cuff 921. The passage 923 terminates in an inflatable cuff 921, as shown in FIG. Positioning assembly 920 includes a silicone balloon that is connected to the housing opposite the introducer assembly. Silicone balloons are preferred for several reasons. First, unlike other polymeric balloons, silicone balloons have a material inflation capacity of up to 800% and return to their original shape when deflated. Other materials require "pre-forming" before being incorporated into the device, and such devices are much bulkier and, once used for their clinical purpose, cannot completely shrink. Utilizing silicone promotes a low profile balloon that can be flush with the multi-lumen housing to which it is attached. Also, details and smooth transitions at the end of the housing--from the balloon to the housing may be affected.

[0157] Housing 910 includes a central channel. The housing is formed of a multi-layer assembly including a fluorinated polymer core from which a polyurethane layer has been extruded. A multi-chain wire braid is placed on top of the polyurethane layer from which the multi-lumen polymer profile has been co-extruded. This housing configuration offers certain advantages. First, the coefficient of friction of the inner surface of the housing is low, which aids the passage of both the penetrating device and the visualization device through the lumen. The blade layer provides torsion resistance, rotational force and flexibility to the housing. Placing the blade in multiple lumens allows for non-destructive access to surrounding lumens. In addition, the co-extrusion assembly
Provide a thermoplastic outer surface to which the positioning assembly can be easily attached.

Alternatively, the housing can include a multi-lumen polymer profile to which a multi-chain wire braid is attached. Thereafter, the assembly receives a polymer coating that bonds the three tubular layers together.

Previous introducer sheath devices have failed to control the loss of a significant amount of blood due to the open end of the introducer sheath device located outside the body. Others have attempted to prevent this blood loss by using complex clamping systems. The present invention provides a unique sealing device that prevents significant blood loss. Introducer sheath device 900
Effectively seals the small surgical device of the present invention, which is typically 3 mm in diameter. Currently available surgical devices used in similar procedures typically have diameters of 6 to 9 mm.
Range. The use of these large diameter devices in combination with currently available introducer sheaths causes significant blood loss. The sheath 900 can be used with these large diameter devices without significant blood loss due to its innovative sealing device.

A seal 930 located at one end of the housing 910 adjacent to the opening 912 prevents significant blood loss. Seal 930 includes an expansion housing assembly 931. A self-sealing gel 932 is disposed within the expansion housing assembly 931. This material 932 allows for insertion of the repair device through material 932, forming a seal around the repair device. As the repair device is removed from introducer sheath device 900 and sealing material 932, material 932 forms a seal behind the repair device that is removed through opening 912.

A detailed view of the seal 930 is shown in FIG. Seal assembly 930
May include an expansion housing assembly 931 and an end cap 935.
The sealing material 932 is preferably a sphincter-shaped polymer gel having an opening for receiving the surgical device 940. Surgical or repair device 940
Is removed from the sheath 900, the sphincter-like opening of the substance 932 closes, creating a tight seal and preventing blood loss. The sealing material 932 rests on a ledge or seat 936 located in the housing assembly 931. Seal substance 93
2 is held in place by a retaining ring 933, which is fixed inside the housing assembly 931.

The extension housing assembly 931 is permanently attached to the housing 910 at 915, as shown in FIG. An injection port 925 is provided that allows for the supply or removal of a liquid or gas that causes the cuff 921 to expand or contract. The liquid or gas is supplied from the injection port via the lumen 923 shown in FIG.
Move to 21.

[0163] Seal 930 can be used with or without end cap 935. End cap 935 provides additional protection against blood loss. End cap 935 is inserted into opening 912 of expansion housing assembly 931 opposite housing 910. The end cap is mounted on the housing assembly 931.
And a thumbwheel-type circular plate portion 938 for facilitating connection with the base plate. The end cap 935 has internal and external sealing means. The internal sealing means includes a surgical device 940 and an end cap 935.
And a V-shaped sealing ring 937 that provides a liquid tight seal between the two. External sealing means is provided by an outer groove 939 and a sealing ring 934. Sealing ring 934
Is preferably an O-ring formed from a polymer material. End cap 9
35 can be modified as needed to accommodate different surgical devices. However, the expansion housing assembly 931 can accommodate a variety of devices without modification.

The multi-port introducer assembly includes a guideway for balloon inflation (assembly positioning), pressure monitoring / fluid control (IVA), and seat protector entry. Except for the details of the seal and cap, the multi-port introducer assembly is insert molded around the housing. The seal comprises a thermoplastic elastomer molding with a lubricious polymer coating that forms a blood-tight seal around the insertion device having a very small diameter, while at the same time allowing easy rotation of them within the introducer assembly. . The cap component snaps into the introducer mold to properly hold the seal component.

The general arrangement of the sheath device 900 is shown in FIG. The surgical or repair device 940 is inserted into the housing 910 through a seal 930 located outside the skin 950. As described above, a positioning assembly 920 is positioned proximate to the aneurysm to maintain accurate orientation of the sheath 900 within the vessel.

However, it will be apparent to those skilled in the art that various changes and modifications can be made in the structure and arrangement of the present invention without departing from the scope or spirit of the invention. The present invention
It is intended to cover the modifications and variations of the invention provided they come within the scope of the appended claims and their equivalents.

Method for Repairing Aneurysm Reference is now made to details of a preferred embodiment of a method for repairing an aneurysm using the above-described components according to the present invention.

Endovascular Endoscope (IVA) -Based Repair Procedure An endoscopic (IVA) -based repair procedure is described in connection with the use of the proximal and distal graft assemblies 10 and 20. Introducer sheath device 900
Is placed by femoral artery incision of both common iliacs under radiological guidance so that the positioning assembly 920 is positioned at the common iliac / femoral bifurcation transition. The guidewire is supplied from one femoral incision to another, also under guidance.
The distal graft assembly 20 includes an attachment cuff 2 as shown in FIG.
1 is fed over the guidewire until it appears directly on the tracheal bifurcation at the bifurcation.

Next, a second guide wire 160 is provided under radiological guidance between the one femoral incision and the left axillary incision. Another introducer sheath device 900 is delivered from the axilla until the time that the positioning assembly 920 reaches the subrenal aorta and expands. Next, the repair device 5 is delivered over the guide guide 160 through the introducer sheath device 900 from either the thigh or axilla access to the central point of the aortic aneurysm. Next, the visualization device 6 is supplied through the hollow interior 211 of the housing 200 to the part of the wall 2 where the attachment cuff 22 is mounted. Next, the guide wire 17
By manipulating 0, the orientation of the visualization device 6 is adjusted to enable the observation of the wall 2 described above, so that the image appears on the monitor. The image of wall 2 appears on the monitor. Next, the visualization device 6 is removed and the penetrating device 7 is inserted through the hollow interior 211.
As described above, the guide wire 170 causes the penetrating device to be located at the same position as the visualization device 6. The tracking means 440 pinpoints the position of the penetrating means 420 with respect to the wall 2 and the attachment cuff 22, as observed on a monitor. Next, the first and second penetrating means 420 and 430 are operated to form treatment-specific holes in the cuff 22 and the wall 2 as described above. Next, the first penetrating means 420 is removed, and the fastening device is inserted into the treatment-specific hole using the inserting means 450. Next, the position of the penetrating device 7 is adjusted and the process is repeated over the site previously observed by the visualization device 6. next,
The penetrating device 7 is removed and the visualization device 6 is reinserted. The observation and locking process
Repeat alternately until attachment cuff 22 is firmly attached to wall 2.

Once the repair device 5 has been removed, the attachment cuff 22 is fixed to the wall 2.
Next, the proximal graft assembly 10 is inserted through the femoral incision in the reverse manner over the guidewire 160 to the position shown in FIG. Next, the repair device 5 is delivered over the guidewire 160 through the introducer sheath device 900 from either the thigh or axilla access to a position adjacent to the attachment cuff 12. Next, the visualization device 6 and the penetrating device 7 are inserted alternately in the manner described above, and the attachment cuff 12
Is fixed. If a standard graft 3 is used, the inverted graft 3 is fixed directly to the wall 2 in a similar manner. Alternatively, the self-expanding stent 30 can be used with a locking device to secure the graft 3 to the wall 2. Next, the repair device 5 is removed.

Once the proximal graft assembly 10 or 3 is properly secured, the first guidewire is removed and the graft 3 or 10 is inserted. Next, the tubular leg 11 is inserted into the attachment tube 22. Next, using the self-expanding stent 30, the attachment tube 22 and the tubular leg 11 are firmly fixed together. Next, the guide wire 160 is removed. The positioning assembly 920 is retracted and the introducer sheath device 900 is removed from the femoral and axillary arteries. Next, the incision is closed to complete the repair process. The procedure according to the invention outlined is much less invasive than currently known methods. As a result, the patient's recovery period will be reduced.

Intravascular Ultrasound Repair Intravascular ultrasonic repair is described with reference to the use of the proximal and distal graft assemblies 10 and 20. The introducer sheath device 900 may be deployed by femoral artery incision in both iliacs under radiological guidance, such as a positioning assembly 920, as described above in connection with an endovascular (IVA) based repair procedure. Is done. The distal graft assembly 20 is fed over the guidewire as described above until the attachment cuff 21 appears directly on the tracheal bifurcation, as shown in FIG.

Next, a second guidewire 160 is provided under radiological guidance between the one femoral incision and the left axillary incision. Another introducer sheath device 900 is delivered from the axilla until the time that the positioning assembly 920 reaches the subrenal aorta and expands. Next, the repair device 50 is delivered over the guide guide 160 through the introducer sheath device 900 from either the thigh or axilla access to the central point of the aortic aneurysm. Next, the visualization device 600 is supplied to the part of the wall 2 where the attachment cuff 22 is attached. The scanning catheter is pulled caudally to provide an image of the common iliac translocation of the distal aorta on an external monitor. Next, the repair device 50 is oriented so that the penetrating device 700 is adjacent to the site where the attachment cuff 21 is attached to the wall 2.

Next, the first and second penetrating means 420 and 430 are operated to form treatment-specific holes in the cuff 22 and wall 2 as described above. Next, the first penetrating means 420 is removed, and the fastening device is inserted into the treatment-specific hole using the inserting means 450. Next, the position of the penetrating device 700 is adjusted, and the process is repeated over the site previously observed by the visualization device 600. Next, the repair device 50 is oriented so that the visual device 600 can scan another part of the wall 2. The observation and installation process
Repeat alternately until attachment cuff 22 is firmly attached to wall 2.

Once the repair device 50 has been removed, the attachment cuff 22 is fixed to the wall 2. Next, the proximal graft assembly 10 is inserted through the femoral incision in the reverse manner over the guidewire 160 to the position shown in FIG. Next, the repair device 50 is inserted through the introducer sheath device 900 over the guidewire 160 from either the thigh or axilla access to a position adjacent to the attachment cuff 12. Next, the visualization device 600 and the penetrating device 700 are inserted alternately in the manner described above, and the attachment cuff 12 is fixed to the wall 2.

Once the proximal graft assembly 10 has been properly secured, the first guidewire and repair device 50 are removed and the graft 10 is inserted. Next, the tubular leg 11 is inserted into the attachment tube 22. Next, using the self-expanding stent 30, the attachment tube 22 and the tubular leg 11 are firmly fixed together. Next, the guide wire 160 is removed. The positioning assembly 920 is retracted and the introducer sheath device 900 is removed from the femoral and axillary arteries. Next, the incision is closed to complete the repair process.

Although the invention has been described with reference to specific embodiments thereof, many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, the preferred embodiments of the invention described herein are intended to be illustrative, not limiting. Various changes may be made without departing from the spirit and scope of the invention as set forth in the following claims.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described in conjunction with the following drawings, in which like reference numerals indicate like structural elements.

FIG. 1 is a perspective view showing a bifurcated graft graft and cuff assembly according to a preferred embodiment of the present invention.

FIG. 2 is a perspective view of a bifurcated graft and cuff assembly according to another embodiment of the present invention.

FIG. 3 is a perspective view showing the artificial bifurcation graft and cuff assembly of FIG. 1 secured within the abdominal aorta.

FIG. 4 is a perspective view showing the prosthetic branch graft and cuff assembly of FIG. 2 secured within the abdominal aorta.

FIG. 5 is a perspective view showing an artificial branch vessel graft and a cuff according to another embodiment of the present invention.

6 is a perspective view showing the artificial branch graft and cuff of FIG. 5 secured within the abdominal aorta.

FIG. 7 is a perspective view showing the connection between the vascular graft and the cuff.

FIG. 8 is a side view showing the vascular graft of FIG. 6 secured to a second cuff.

9 is an exploded perspective view showing a connection between the artificial vascular graft shown in FIG. 8 and a second cuff.

FIG. 10 is a perspective view showing an attachment cuff according to another embodiment of the present invention.

FIG. 11 is a perspective view illustrating a flexible attachment cuff according to another embodiment of the present invention.

FIG. 12 is a perspective view showing the attachment cuff of FIG. 10 with an artificial vascular graft secured between the attachment cuffs.

FIG. 13 is a perspective view of an endovascular (IVA) -based repair system according to an embodiment of the present invention that includes an embodiment of a visualization device according to the present invention.

FIG. 14 is an end view showing a vascular endoscope (IVA) -based repair system according to the embodiment of FIG.

FIG. 15 is an end view showing the visualization device shown in FIG. 13;

FIG. 16 is another perspective view of an endovascular (IVA) based repair system illustrating a guide wire and an associated cable exiting the housing of the repair system.

FIG. 17 shows a vascular endoscope (IVA) according to an embodiment of the present invention including an embodiment of a penetrating device according to the present invention and an embodiment of a locking device cartridge according to the present invention.
1) is a perspective view showing a base repair system.

FIG. 18 is a perspective view of an endovascular endoscope (IVA) -based repair system according to another embodiment of the present invention containing a penetrating device and a locking device cartridge according to the present invention.

FIG. 19 includes a penetrating device and a locking device cartridge according to another embodiment of the present invention.
FIG. 14 is a perspective view illustrating an endovascular endoscope (IVA) -based repair system according to an eighth embodiment.

FIG. 20 is a perspective view of an endovascular endoscope (IVA) based repair system according to another embodiment of the present invention containing a penetrating device and a locking device cartridge according to the present invention.

FIG. 21 is an end view showing a penetrating device according to an embodiment of the present invention.

FIG. 22 is an end view showing a locking device cartridge according to another embodiment of the present invention.

FIG. 23 is an end view showing the locking device cartridge according to the embodiment of FIG. 17;

FIG. 24 is a perspective view showing an advance mechanism of a penetrating device according to an embodiment of the present invention.

FIG. 25 is a schematic view showing another advancement mechanism of the penetrating device and the locking device cartridge according to another embodiment of the present invention.

FIG. 26 illustrates an intravascular ultrasound (b) according to another embodiment of the present invention that includes a visualization device and a penetrating device.
FIG. 4 is a perspective view showing an (IVUS) base repair device.

FIG. 27 illustrates intravascular ultrasound (FIG. 27) according to another embodiment of the present invention that includes a visualization device and a penetrating device.
FIG. 4 is a perspective view showing an (IVUS) base repair device.

FIG. 28 is a sectional view showing a housing according to an embodiment of the present invention.

FIG. 29 is an end view showing the penetrating device shown in FIG. 26;

FIG. 30 is a perspective view of a wire fastening device for securing a cuff detail of a surgical cuff to a vessel wall according to an embodiment of the present invention.

FIG. 31 is a perspective view of a wire fastening device for securing a cuff detail of a surgical cuff to a blood vessel wall according to an embodiment of the present invention.

FIG. 32 is a perspective view of a wire fastening device according to another embodiment of the present invention for securing a cuff detail of a surgical cuff to a vessel wall.

FIG. 33 is a perspective view of a wire fastening device according to another embodiment of the present invention for securing a cuff detail of a surgical cuff to a vessel wall.

FIG. 34 is a perspective view of a wire fastening device according to another embodiment of the present invention for securing a cuff detail of a surgical cuff to a vessel wall.

FIG. 35 is a perspective view of a wire fastening device according to another embodiment of the present invention for securing a cuff detail of a surgical cuff to a vessel wall.

FIG. 36 is a perspective view showing a locking device according to another embodiment of the present invention for securing a cuff to a vessel wall.

FIG. 37 is a perspective view of a fastening device for securing a cuff to a vessel wall according to another embodiment of the present invention.

FIG. 38 is a perspective view showing a locking device according to another embodiment of the present invention for securing a cuff to a vessel wall.

FIG. 39 is a perspective view of a fastening device according to another embodiment of the present invention for securing a cuff to a vessel wall.

FIG. 40 is a perspective view of a fastening device according to another embodiment of the present invention for securing a cuff to a vessel wall.

FIG. 41 is a perspective view of a locking device according to another embodiment of the present invention for securing a cuff to a vessel wall.

FIG. 42 is a schematic diagram showing an embodiment of a penetrating device according to the present invention having the locking device shown in FIGS. 34, 37, 38 and 39 stored thereon.

FIG. 43 is a schematic diagram showing another embodiment of a penetrating device according to the present invention having the locking device shown in FIGS. 36, 37, 38 and 39 stored therein.

FIG. 44 is a perspective view illustrating a fixation device attachment of a cuff detail to a vessel wall using the fixation device shown in FIGS. 34 and 35 according to an embodiment of the present invention.

FIG. 45 is a perspective view illustrating a fastening device attachment of a cuff detail to a vessel wall using the fastening device shown in FIGS. 34 and 35 according to an embodiment of the present invention.

FIG. 46 is a perspective view showing another embodiment of an endovascular (IVA) based repair system according to another embodiment of the present invention.

FIG. 47 is a perspective view showing an introducer sheath device according to the present invention.

FIG. 48 is a cross-sectional view illustrating a sealing assembly of an introducer sheath device according to an embodiment of the present invention.

FIG. 49 is a perspective view of a locking device according to another embodiment of the present invention.

FIG. 50 is a perspective view of a locking device according to another embodiment of the present invention.

FIG. 51 is a perspective view of a locking device according to another embodiment of the present invention.

FIG. 52 is a perspective view showing a locking device according to another embodiment of the present invention for securing a cuff to a vessel wall.

FIG. 53 is a perspective view of a fastening device for securing a cuff to a vessel wall according to another embodiment of the present invention.

FIG. 54 is a cross-sectional view illustrating a sealing assembly of an introducer sheath device according to an embodiment of the present invention.

FIG. 55 is a perspective view showing an introducer sheath device and a sealing assembly for the present invention.

FIG. 56 is a perspective view showing a locking device according to another embodiment of the present invention.

FIG. 57 is a perspective view showing a fastening device according to another embodiment of the present invention.

FIG. 58 is a perspective view showing a fastening device according to another embodiment of the present invention.

FIG. 59 is a perspective view showing a fastening device according to another embodiment of the present invention.

FIG. 60 is a perspective view of another IVA-based repair system according to another embodiment of the present invention.

FIG. 61 is a perspective view of another IVA-based repair system according to another embodiment of the present invention.

FIG. 62 is a perspective view of another IVA-based repair system according to another embodiment of the present invention.

Claims (26)

[Claims] 1. A repair device for repairing a blood vessel during a surgical procedure, the device comprising a housing, and a penetrating device and a surgical device for use in forming a therapy-specific hole in the blood vessel. The housing includes at least one visualization device for visualizing the interior of a blood vessel during a procedure, wherein the housing includes a plurality of layers surrounding a central path, the central path including the at least one of the penetrating device and the visualization device. Restoration device adapted to accommodate one of the. 2. The repair device of claim 1, wherein the housing further comprises at least one lumen formed in one of the plurality of layers. 3. The repair device of claim 2, wherein the at least one lumen includes a plurality of lumens, the plurality of lumens being provided radially about the central path. 4. The system of claim 3, wherein the plurality of lumens and the central path are coaxial.
A repair device according to claim 1. 5. The repair device according to claim 1, wherein the housing has a proximal end and a distal end. 6. A distal end assembly disposed adjacent said distal end of said housing, said distal end assembly connecting said at least one of said penetrating device and one of said visualization devices. Allowing access to blood vessels,
The repair device according to claim 5. 7. The system further comprises at least one engagement line for controlling engagement of the distal end assembly, wherein the at least one engagement line is from a distal end of the housing to the proximal end of the housing. And the at least one engagement line is adapted to be connected to a repair controller, and the operation of the at least one engagement adjusts the arcuate orientation of the distal end assembly within the vessel. , Claim 6
A repair device according to claim 1. 8. The apparatus of claim 8, wherein the housing further comprises at least one lumen formed in one of the plurality of layers, wherein the at least one engagement line extends through the at least one lumen. Item 8. The repair device according to Item 7. 9. The repair device according to claim 1, further comprising a positioning assembly for positioning the repair device in a blood vessel. 10. The repair device of claim 9, wherein the positioning assembly is located adjacent at least one end of the housing. 11. The repair device of claim 10, further comprising control means for controlling operation of the positioning assembly, wherein the control means extends through the housing. 12. The positioning assembly comprises an inflatable assembly.
The repair device according to claim 11. 13. The repair device of claim 12, wherein said control means includes inflation means for inflating said inflatable assembly. 14. The inflation means includes: at least one lumen extending through the plurality of layers; and an inflation port connected to the at least one lumen, the inflation port proximate the housing. 14. The repair device of claim 13, wherein the repair device is disposed adjacent to the post. 15. The repair device of claim 1, wherein the plurality of layers include at least a first layer surrounding the central path and a wire braid layer. 16. The repair device of claim 15, wherein the plurality of layers further comprises an outer layer, the outer layer surrounding the wire braid layer. 17. The repair device of claim 16, wherein the plurality of layers further comprises a projecting layer positioned between the first layer and the wire blade layer. 18. The repair device according to claim 16, further comprising at least one lumen formed in the outer layer. 19. The repair device of claim 18, further comprising a guide line extending through one of the at least one lumen. 20. The repair device of claim 18, further comprising at least one engagement line extending through one of the at least one lumen. 21. The repair device of claim 1, wherein the penetrating device comprises a laser. 22. The penetrating device comprises a low OH polyamide coated optical fiber.
A restoration device according to claim 21. 23. The repair device of claim 22, wherein said laser is a Holmium Yag laser. 24. The repair device of claim 1, wherein the penetrating device comprises a piezoelectric penetrating catheter. 25. The repair device of claim 24, wherein the penetrating device comprises a high frequency driven electrocautery probe. 26. The repair device of claim 24, wherein the penetrating device comprises a radio frequency powered electrocautery probe.